Status:
COMPLETED
Rituximab Treatment in Sjogren's Syndrome
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Sjogren's Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.
Detailed Description
Study design: phase II trial Study objective: evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in pati...
Eligibility Criteria
Inclusion
- Stimulated whole saliva secretion ≥ 0,15 ml/min
- Male or female \> 18 years
- Primary SS according to the revised European - U.S. criteria(22)
- Positive autoantibodies (IgM-Rf \> 10 and SS-A and/or SS-B)
- Parotid gland biopsy (paraffine material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago)
- Use of reliable method of contraception during the study
- Written informed consent
Exclusion
- The presence of any other connective tissue disease
- Preceding treatment with anti-TNF or other monoclonal antibodies
- Use of prednisone, hydroxychloroquine less than 1 month ago
- Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than 0,5 year ago
- Serum creatine \> 2.8 mg/dl (250 micromol/l)
- ASAT or ALAT outside 1.5 x upper normal range of the laboratory
- Hb \< 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
- Neutrophil granulocytes less than 0.5 x 109/l
- Platelet count less then 50 x 109/l
- Positive pregnancy test or breast-feeding
- History of alcohol or drug abuse
- Serious infections
- Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study
- History of any malignancy with the exception of completely resected basal cell carcinoma of the skin
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00363350
Start Date
August 1 2006
End Date
October 1 2008
Last Update
February 24 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9700 RB